Is Industry Influence Causing Heart Stents to Be Overused?

According to a newly-published study, fewer than half of Americans with stable heart disease get guideline-recommended medicines before undergoing angioplasty with coronary stents â€“ a procedure also known as percutaneous coronary intervention or PCI. A new investigation from ProPublica suggests that the rush to use stents by many doctors could be the result of heavy financial influence from the makers of stents.

For several years now, scientific guidelines have called on doctors to try drug therapy â€“ statins, beta blockers, or aspirin â€“ before resorting to angioplasty. Those guidelines were instituted after a 2007 landmark study showed that intensive drug treatment in nonemergency patients with chest pain worked as well as angioplasty. The same study also suggested that many of those given drugs first wouldnâ€™t need an eventual angioplasty. Before that study was published, fewer than half of PCI patients received drug treatment first, then an angioplasty.

Now a new report published in the Journal of the American Medical Association (JAMA) is showing that not much has changed since 2007. In the first two years after the landmark PCI study was published, the number of patients treated with drugs first increased only slightly, to about 45 percent.

The ProPublica report details several outrageous instances of stent overuse, including a case in which 141 patients underwent unneeded angioplasties at Westmoreland Hospital in Western Pennsylvania in 2010. According to a report from The Pittsburgh Tribune Review, the questionable stents were implanted by Drs. Ehab Morcos and George Bousamra, who voluntarily resigned their privileges at Westmoreland in January.

We’ve discussed this subject on this blog before. In December, we reported that Baltimore surgeon Mark Midei had come under scrutiny of implanting allegedly unnecessary cardiac stents in hundreds of patients. It turned out that Abbott Laboratories, a stent manufacturer, was funding lavish parties at Mideiâ€™s house and working on a business plan that involved the physicianâ€™s numerous surgeries. Midei was ranked as one of Abbottâ€™s top-volume surgeons in the Northeast U.S. region, Abbottâ€™s business plan included funding Mideiâ€™s research and sending him on â€œVIP trips.â€ All of this coincided with an uptick in Midei’s usage of Abbott’s stents.

According to the new ProPublica report, Midei could now lose his license, and stands accused of implanting stents unnecessarily in more than 500 patients.

But it’s not just individual doctors like Midei who receive financial support from stent makers. According to ProPublica, the Society for Cardiac Angiography and Interventions (SCAI) received 57 percent of its revenues in 2009 from medical device and pharmaceutical makers. Cordis Corp., Boston Scientific, Abbott Laboratories and Medtronic – the companies with the biggest share of the stent market – were the biggest funders.

The group’s head, Dr. Larry Dean, told ProPublica that industry funding doesn’t play a role in the formulation of its treatment guidelines. As far as doctors performing unnecessary angioplasties, Dean told ProPublica that his group “is not a ‘policing agency’ but takes the issue seriously and would expel any doctor found guilty of inappropriately implanting them.”

There is evidence, however, that financial support from the industry does influence some groups. According to ProPublica, the Heart Rhythm Society, which gets half its revenue from the medical products industry, has left out or downplayed risks and limitations of cardiac devices and procedures.

In 2008 and 2009, Sens. Charles Grassley, R-Iowa, and Herb Kohl, D-Wis., targeted the Cardiovascular Research Foundation, which is affiliated with Columbia University. According to ProPublica, they accused the group’s leaders of failing disclose contributions from industry to the university. In 2009, Columbia University adopted a new policy on financial conflicts of interest in research.